Progress: 10-14 studies have been funded, which is more than the minimum recommended, and momentum within the pre-clinical phases of this objective is currently building. It should be noted, however, in that many of these studies are small trials or pilot studies.Â

Remaining Gaps, Needs, and Opportunities: Though there is little evidence that CNS drug development in animals will translate to humans, either in terms of toxicity or efficacy, there is still a need for investment in well-established animal model studies to identify promising molecular, cellular, or systems targets before mounting randomized clinical trials in humans. However, existing drugs for other indications may be adapted to ASD without extensive pre-clinical work, and there is also evidence for proof of concept studies for ASD (particularly those addressing core symptoms). It is also critically important to develop appropriate outcome measures for use in trials.